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Trial record 1 of 1 for:    NCT00393939
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Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer (SUN 1064)

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ClinicalTrials.gov Identifier: NCT00393939
Recruitment Status : Completed
First Posted : October 31, 2006
Results First Posted : February 28, 2011
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 30, 2006
First Posted Date  ICMJE October 31, 2006
Results First Submitted Date  ICMJE January 31, 2011
Results First Posted Date  ICMJE February 28, 2011
Last Update Posted Date July 19, 2012
Study Start Date  ICMJE February 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 33 ]
PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2006)
Progression-free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • Percentage of Participants With Objective Response [ Time Frame: Baseline up to Month 33 ]
    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.
  • Duration of Response (DR) [ Time Frame: Baseline up to Month 33 ]
    DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.
  • Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to Month 33) ]
    Time from randomization to date of death due to any cause. OS calculated as (Months) = (death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.
  • Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]
    EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.
  • Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]
    EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.
  • Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ]
    EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled 'best imaginable health state' and 'worst imaginable health state'. Change from baseline = score for Cycle/Day minus baseline score.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2006)
Overall survival Overall response rate Duration of response Patient reported outcome changes Overall safety profile.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Official Title  ICMJE A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
Brief Summary This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Sunitinib malate
    Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
  • Drug: Taxotere
    Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Sunitinib malate
  • Active Comparator: B
    Intervention: Drug: Taxotere
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2010)
594
Original Enrollment  ICMJE
 (submitted: October 30, 2006)
550
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
  • Her-2 negative tumors

Exclusion Criteria:

  • Patients for whom docetaxel is contraindicated
  • Clinical presentation of inflammatory carcinoma with no other measurable disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Netherlands,   Panama,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00393939
Other Study ID Numbers  ICMJE A6181064
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP